Pfizer Experimental Bone Drug Shows Mixed Results In Study
Last we heard of Fablyn, an experimental bone drug for the treatment of postmenopausal women, U.S. regulators were holding off on approval after FDA staff and outside reviewers raised concerns and Pfizer, the pill’s maker, was shopping it around to other companies.
Today’s New England Journal of Medicine reports that the drug met the goals of a key study. Fablyn prevented certain fractures in postmenopausal women and reduced the risk of breast cancer, said the study, sponsored by Pfizer. However, the drug didn’t show a statistically significant benefit preventing debilitating hip fractures. Also, it increased the risk of blood clots by two times.
The Phase 3 study looked at 8,556 women between the ages 59 and 80 over five years. Its mixed results aren’t likely to clarify Fablyn’s future. Here’s a Reuters account of the findings.
The study’s lead author, Steven Cummings of the California Pacific Medical Center Research Institute, said the results show Fablyn’s effectiveness as a second-line treatment for certain postmenopausal women. The drug would be a candidate, he said, for those women coping with osteoporosis who are at high risk of breast cancer but not for spine fractures, which other osteoporosis therapies treat more effectively.
But Carolyn Becker, an osteoporosis […]
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